Kornimate/medical-research-clean huggingface dataset:
prophylactic maze to prevent atrial fibrillation in adult cardiac surgery

Conditions: Coronary Artery Disease

Summary: this study will look at performing a prophylactic limited left sided maze procedure during concomitant adult cardiac surgery to prevent the common occurrence of postoperative atrial fibrillation.

this is a prospective, single site, randomized, small feasibility study using a fda approved device for a new indication. subjects undergoing a cabg, avr, or cabg/avr will be randomized 1 to 1 to a control or treatment group. the control group will undergo their index cardiac surgery procedure only. the treatment group will undergo their index cardiac procedure along with a limited left sided maze procedure. the maze procedure will be done with the atricure synergy ablation system. this is an fda approved device that will be used for this new indication. the left sided limited maze procedure will consist of pulmonary vein isolation and removal of the left atrial appendage. a total of 60 subjects will be enrolled in this study at a single site.

Eligibility criteria:
inclusion criteria: * elective cardiac surgery * avr * cabg * avr/cabg exclusion criteria: * history of af/aflutter * less common cardiac surgeries: * aortic root replacement * aortic dissections * myxoma * pericardectomies * off-pump procedures * redo procedures * subjects with existing pacemakers, aicd * vulnerable population * emergent surgery * currently participating in investigational drug or device study. * subjects currently on antiarrhythmic drugs class i and iii including amiodarone.
the china cardiomyopathy registry study

Conditions: Cardiomyopathies

Summary: cardiomyopathy is the most common inherited cardiovascular disease, showing family aggregation, so it has a huge psychological and economic burden on family members. studying the clinical characteristics of patients with cardiomyopathy is helpful for further diagnosis, treatment and management, which has important clinical and social significance.

in this study, patients hospitalized with cardiomyopathy as the primary discharge diagnosis in china are recruited prospectively after informed consent was given. the investigator will collect the baseline clinical characteristics of the patients at enrollment, including comprehensive physical examination, laboratory testing of blood and urine, electrocardiography, 24-hour holter, echocardiography, mri and other examinations if necessary. data are collected with the use of case report forms (crfs) and are entered into a web-based system. a 6 ml venous blood sample is obtained from consenting patients. each participant is scheduled to be followed up by telephone every 12 months after admission to hospital.

Eligibility criteria:
inclusion criteria: * patients with primary discharge diagnosis meeting one of the following subtypes of cardiomyopathy were enrolled, including hcm, dcm, acm, rcm, left ventricular non-compaction, cardiac amyloidosis, fabry disease, pompe disease, danon disease, and prkag2 cardiac syndrome. exclusion criteria: * patients who refuse to sign the informed consent or decline follow-up.
uterine, fetal cerebral doppler and oligohydramnios to predict abnormal heart rate tracings in postterm pregnancies

Conditions: Abnormality in Fetal Heart Rate or Rhythm; Ultrasound; Late Pregnancy

Summary: objective: to estimate the value of uterine, fetal cerebral doppler and oligohydramnios to predict abnormal fetal heart rate tracings in pregnancies at or beyond 41 weeks

this will be a nested case-control study that was conducted at university hospital dr. jose e. gonzalez after the approval of institutional ethical committee. women with low risk late term or postterm pregnancy (at least 41 weeks) with confirm gestational age who will be referred to our maternal-fetal unit and admitted 1 to 2 days prior to induction of labour according institutional protocol will be recruited and constitute the cohort. cases will be patients with abnormal intrapartum cardiotocogram (category iii fetal heart rate tracing). for each case, four controls will be matched. the primary outcome will be to obtain odds ratios for the doppler parameters (middle cerebral artery pulsatility index, mean uterine artery pulsatility index and middle cerebral artery pulsatility index to mean uterine artery pulsatility index ratio) and amniotic fluid index that would be associated with intrapartum category iii fetal heart rate tracing.

Eligibility criteria:
inclusion criteria: * singleton pregnancy * gestational age of at least 287 days (41 weeks) * low risk pregnancy (defined as the absence of maternal or fetal complications other than postterm pregnancy) exclusion criteria: * twin or multiple gestation * uncertain gestational age * non vertex presentation * estimated fetal weight below the 10th percentile for gestational age (hadlock´s formula) * fetal macrosomia (estimated fetal weight ≥ 4 kilos) diagnosed by clinical measurement (johnson´s technique) or ultrasound measurement (hadlock´s formula). * fetal abnormalities found on routine anomaly scan. * maternal medical disorder (preeclampsia, chronic hypertension, diabetes, lupus, hyperthyroidism) * prelabour rupture of membranes * antepartum hemorrhage * any fetopelvic disproportion that could create dystocia during labor.

Keywords: late term pregnancy doppler
relationship between metabolic profiles and chronic diseases and neoplasms

Conditions: Metabolic Diseases

Summary: metabolic disorders are involved in the occurrence and development of a variety of chronic diseases and tumors. there are many common risk factors between chronic diseases and tumors. however, the mechanisms of chronic diseases and tumors caused by metabolic disorders are not completely clear. by observing the relationship between metabolic indexes and chronic diseases and tumors, the investigators intend to explore the possible mechanisms of metabolic status participating in the occurrence and development of chronic diseases and tumors.

metabolic disorders are involved in the occurrence and development of a variety of chronic diseases and tumors, for example, metabolic diseases (hypertension, diabetes, dyslipidemia, obesity, etc.) can mediate the progression of chronic diseases such as heart failure and ischemic encephalopathy. obesity can increase the risks of endometrial cancer, esophageal cancer, stomach cancer, etc. there are many common risk factors between chronic diseases and tumors, such as age, sex, smoking, genetics, obesity, unhealthy diet and lack of exercise. however, the mechanisms of chronic diseases and tumors caused by metabolic disorders are not completely clear. by observing the relationship between metabolic indexes and chronic diseases and tumors, the investigators intend to explore the possible mechanisms of metabolic status participating in the occurrence and development of chronic diseases and tumors.

Eligibility criteria:
inclusion criteria: * adult aged ≥18 years old * completed health screening exclusion criteria: * aged \<18 years old * pregnancy
a study of v419 given concomitantly with prevnar 13™ and rotateq™ (v419-006)

Conditions: Bacterial Infections; Virus Diseases

Summary: this study will determine whether three manufacturing lots of v419 (pr5i) induce similar immune responses to all of the antigens contained in v419 when given concomitantly with prevnar13™ and rotateq™.

this study is partially double-blinded in that the participants' parents/guardians, investigator/study site personnel, and sponsor's representatives will be blinded to the lot of v419 the participant is randomized to receive, but not to the participant's treatment group (v419 or control).

Eligibility criteria:
inclusion criteria : * participant is a healthy infant * participant has received one dose of monovalent hepatitis b vaccine prior to 1 month of age exclusion criteria : * participant has received more than one dose of monovalent hepatitis b vaccine or hepatitis b based combination vaccine prior to study entry * participant has been vaccinated with any acellular pertussis or whole cell pertussis based combination vaccines, haemophilus influenzae type b conjugate, poliovirus, pneumococcal conjugate or pneumococcal polysaccharide, rotavirus, measles, mumps, rubella, or varicella vaccines or any combination of the above * participant has had an illness with fever within 24 hours of study enrollment * participant was vaccinated with any non-study vaccine (i.e. inactivated, conjugated or live virus vaccine within 30 days prior to enrollment, except for inactivated influenza vaccine, which is permitted 15 days or more prior to enrollment * participant or his/her mother has hepatitis b surface antigen (hbsag) seropositivity (by medical history) * participant has a history of haemophilus influenzae type b, hepatitis b, diphtheria, tetanus, pertussis, poliomyelitis, rotavirus, or pneumococcal infection

Keywords: diphtheria tetanus whooping cough (pertussis) poliomyelitis hepatitis b infection haemophilus influenzae type b infection
comparative evaluation of an alkasite-based restorative material and two different resin composites

Conditions: Tooth Diseases

Summary: the clinical performance of an an alkasite-based restorative material and two different resin composites will be evaluated and compared in non-carious cervical lesions. after recruiting participants with at least three non-carious cervical lesions, all restorations will be placed by a single clinician. lesions will be divided in three groups: an alkasite-based restorative material (cention n, ivoclar vivadent, schaan, liechtenstein (cn)), hybrid resin composite (gradia direct anterior, gc, tokyo, japan (gd)) and a highly filled flowable resin composite ((g-aenial universal flo, gc, tokyo, japan (gf)). all restorative procedures will be conducted according to manufacturers' instructions. restorations will be scored using fdi criteria. descriptive statistics will be performed using chi-square tests.


Eligibility criteria:
inclusion criteria: * age range will be 18 to 65. * they will be required to have at least three nccls needed restoration in different teeth. * all the nccls selected will be in similar sizes. exclusion criteria: * patients with severe periodontal disease * patients with rampant, uncontrolled caries * patients with xerostomia * patients with serious medical problems preventing them from attending review visits * patients with poor gingival health * patients with heavy bruxism * patients with removable partial dentures * patients undergoing bleaching treatment or orthodontic treatment
efficacy and safety comparative study of sitagliptin,vildagliptin and saxagliptin

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to explore the differences in efficacy and safety of sitagliptin,vildagliptin and saxagliptin and to find which one is more better in treating type 2 diabetes mellitus.


Eligibility criteria:
inclusion criteria: * signed the informed consent * diagnosed with t2dm * women of childbearing potential were required to have a negative urine; pregnancy test,and agreed to use adequate contraception throughout the; study and for up to 4 weeks after completion * glycosylated hemoglobin ranged in 6.5-9.5% exclusion criteria: * patients in pregnancy or lactation period * ever received any kind of oral hypoglycemic drug in recent 3 months * patients were currently receiving treatment with a cytochrome p450 3a4 inducer or depressor,a systemic corticosteroid,or a human immunodeficiency virus anti-viral medication * gastrointestinal surgery that could affect drug absorption * patients with haemoglobinopathy or rapidly progressing renal disease, or autoimmune skin disorder * a recent history of alcohol or drug abuse within the past 12 months * any contraindication listed in the package inserts of the study drugs * a history of acute or chronic pancreatitis or currently * type 1 diabetes; a history of diabetic ketoacidosis or hyperosmolar nonketonic coma * new york heart association class iii or iv congestive heart failure; left ventricular ejection fraction ≤ 40%; a major cardiovascular event within the past 6 months * significant abnormal liver function, defined as aspartate aminotransferase or alanine aminotransferase \> 2 times the upper limit of normal or total bilirubin \>34 µmol/l (\> 2 mg/dl); or a history of positive serologic evidence of infectious liver disease * clinical signs or symptoms of active liver disease and/or significant abnormal liver function * patients with any clinically significant abnormality identified on physical examination, electrocardiogram (ecg), or laboratory tests that, in the judgment of the investigator, would compromise the patients' safety or successful participation in the clinical study * fasting plasma glucose level \> 13.3mmol/l * creatinine clearance rate ≤ 90ml/min

Keywords: sitagliptin vildagliptin saxagliptin diabetes mellitus, type 2
efficacy evaluation of surfactant administration via laryngeal mask airway

Conditions: Respiratory Distress Syndrome, Newborn

Summary: with the development of the intubation surfactant extubation technic, in which surfactant is administered during a brief intubation followed by immediate extubation, surfactant therapy can be given during nasal continuous positive airway pressure treatment further reducing need for mechanical ventilation. preterm newborn babies until eight hours of life, with respiratory distress syndrome, will be randomized to standard delivery of surfactant via endotracheal tube airway inserted after premedication for pain with midazolam and remifentanil or to surfactant delivery via proseal laryngeal mask airway size 1. the intent is to is to compare efficacy and safety of surfactant administration via two different airways and ventilatory approaches.


Eligibility criteria:
inclusion criteria: * birthweight more than 1000 grams * gestational age more than 28 weeks and less than 35 weeks * chronologic age less than 8 hours * diagnosis of rds by clinical and radiographic criteria * treated with nasal continuous positive airway pressure and supplemental oxygen more than 30% * parental consent exclusion criteria: * birthweight less than 1000 grams * gestational age more than 28 weeks and less than 35 weeks * chronologic age more than 8 hours * maternal fever or premature rupture of fetal membranes less than 18 hours * diagnosis other than respiratory distress syndrome * babies who require or have already had endotracheal intubation * analgesia and or sedation during the first six hours of life * apgar 5 minute score less than three * babies with congenital anomalies or signs of acute circulatory failure

Keywords: tracheal intubation proseal laryngeal mask airway neonate surfactant respiratory distress syndrome
influence of nutritional and inflammational status on survival of hemodialysis patients

Conditions: Inflammation; Body Composition

Summary: prospective longitudinal measurements of nutritional status parameters (body composition by bia, anthropometry and biochemical indexes), inflammatory response (crp, inflammatory cytokines (il-1, il-6, il-10),igf-1, leptin and nox blood levels) and morbidity and mortality data collection over 2 year period in patients receiving chronic hemodialysis.


Eligibility criteria:
inclusion criteria: * male or female, age \> 18 years, in chronic hemodialysis treatment at least 3 months * stable and adequate hemodialysis treatment three months prior to participation in study as defined by kt/v \> 1.2 and/or hemodialysis performed 4 hours 3 times weekly * patients with normal hydration status (edema-free), with no neuro-muscular diseases * informed consent obtained before any trial-related activities exclusion criteria: * patients with edema, pleural effusion or ascites at their initial assessment * patients with active malignant disease or liver cirrhosis * patients with neuro-muscular diseases * patients on chronic treatment with steroids on doses \> 10 mg/day prednisone (or equivalent) * patients treated with immunosuppressive agents * patients suffering from * acute vasculitis * severe systemic infections * heart failure (nyha class iii-iv) * the receipt of any investigational drug within 1 month prior to initiating of this study
mindfulness, exercise and nutrition to optimize resilience for individuals with a spinal cord injury.

Conditions: Spinal Cord Injuries

Summary: the purpose of this study is to examine the effects of onsite and telehealth programs for individuals with spinal cord injury. the primary aim of this study is to compare the effectiveness of a blended 5-day onsite health promotion program followed by a 12-month telehealth package composed of exercise, nutrition, and mindfulness, to a 12-month telehealth-only package in individuals with spinal cord injury. the investigators hypothesize that the blended onsite and telehealth program will achieve better gains in fitness, dietary control, body composition, and pain management scores across a one-year period in comparison to the telehealth-only group. the secondary objective of this study is to examine changes in psychosocial mediators between the two groups to determine if key social cognitive theory constructs were significantly different between the two groups. the investigators hypothesize that the blended onsite and telehealth program will achieve better improvements in these outcomes compared to the telehealth only group.


Eligibility criteria:
inclusion criteria: * sci ≥ 1 year post injury * able to use arms for exercise * 18-60 years old * reliable access to the internet * ability to prepare own food, or have input into person responsible for food preparation * can provide own self-care. exclusion criteria: * cognitive impairment * depression * poorly controlled blood pressure (sbp ˃ 159 or dbp ˃ 95 mm hg) * cardiovascular disease event within the past six months * severe pulmonary disease * renal failure * current use of insulin or sulfonylurea agents * current use of medications for psychosis or bipolar disorder * active pressure ulcers

Keywords: spinal cord injuries sci telehealth mindfulness nutrition exercise
acute effects of fruit juices consumption on postprandial glycemic responses and satiety

Conditions: Potential Abnormality of Glucose Tolerance; Appetitive Behavior

Summary: this study investigated the acute effects of two fruit juices on postprandial glycemic responses and satiety in healthy individuals

this study aimed to 1. determine the glycemic index and glycemic load of two types of fruit juices (orange juice and mixed fruit juice consisted of apple, orange, grape, and pomegranate) and 2. investigate the effects of these two fruit juices on postprandial glycemic responses and satiety in healthy individuals

Eligibility criteria:
inclusion criteria: * healthy * non-smoking * non-diabetic and normotensive men and women * body mass index between 18.5 and 25 kg/m2 exclusion criteria: * severe chronic disease (e.g. cardiovascular diseases, diabetes mellitus, kidney or liver conditions, endocrine conditions) * gastrointestinal disorders * pregnancy * lactation * competitive sports * alcohol abuse * drug dependency

Keywords: blood glucose fruit juice glycemic index glycemic load satiety
clinical study to evaluate the stentys xposition s for treatment of unprotected left main coronary artery disease

Conditions: Coronary Artery Disease (Left Main)

Summary: prospective, non-randomized, multi-center study assessing the long term safety and efficacy of the self expandable sirolimus eluting xposition s stent in the treatment of unprotected left main coronary artery disease.

in the treatment of unprotected left main coronary artery (ulmca) disease, previous mono-center studies have shown promising results with the previous generation of the self-expandable stentys stent (paclitaxel eluting stent, delivered via withdrawal of a sheath). the trunc study aims at assessing at large scale the xposition s in the treatment of ulmca disease. the xposition s is a sirolimus eluting stent, mounted on a balloon delivery system. the study aims at collecting clinical practice routine data from 200 patients.

Eligibility criteria:
main inclusion criteria: * subject ≥ 18 years old; * presence of coronary artery stenosis in the unprotected left main (lm) coronary artery which is indicated for pci and xposition s stent treatment * left main coronary artery reference vessel diameter ranging from 2.5 mm to 6.0 mm; * the subject is able to provide voluntary informed consent, willing to comply with all study requirements and sign the written informed consent. main exclusion criteria: * recent stemi (\<1 month) ; * syntax score ≥ 33 ; * highly calcified lesions or excessive tortuosity at target lesion site; * subject unable to comply with dual antiplatelet therapy as recommended per guidelines; * planned cardiac surgery or valve intervention within the next 12 months. * participation to other investigational drug or device studies that have not reached their primary endpoint.

Keywords: left main stent self-expandable des stentys
crustacean allergy and dust mites sensitization

Conditions: Food Allergy; Respiratory Allergy

Summary: this study evaluates the diagnostic efficacy of cap system (capsulated hydrophilic carrier polymer) for recombinant tropomyosin from shrimp extract in discriminating between subjects allergic to shrimp with cap positive subjects allergic to mites, crustaceans asymptomatic but with a positive cap to shrimp, to identify those at greatest risk of food reactions.

most epidemiological data related to allergy to shellfish come from the usa, where 2.5% of the adult population is subject to an allergy to shellfish, which is also the leading cause of anaphylaxis in adults in these areas. this allergy affects also the european adult population, so that the crustaceans were included in the european directive 2003/89/ec on the labeling requirement to indicate any allergenic ingredients (listed in annex 3 a) used in the production of a food and present, although in other form, in the finished product. the allergen mainly involved in allergic reactions to shellfish food is the tropomyosin protein of pm of about 34-36 kda, isolated for the first time in the shrimp (pen to 1), involved in the mechanisms of muscle activation and identified in the muscle fiber of many crustaceans (pen i 1, cha f 1, cra c 1, hom a 1, v 1 lit, pan s 1, pen m 1) and molluscs (hel as 1, d 1 hal, cra g 1, oct 1 st, tod p 1). the tropomyosins, identified in many other invertebrates, such as dust mites and cockroaches, seem to be cross-reactive with each other, suggesting the role of allergens inside of the invertebrates. in those circumstances, the positivity of specific ige for the crustaceans can thus be determined also by sensitization to tropomyosin even for simple cross-reactivity with tropomyosin of the mites, which represents a minor allergen der known as p10.

Eligibility criteria:
inclusion criteria: * males and females aged between 18 and 80 years; * patients with clinical manifestations have been discovered and documented allergy to shrimp and / or mite in which both demonstrated ige-mediated mechanism (cap system for shrimp and / or mite positive); * patients with questionable symptoms to shellfish are tested for unleashing double-blind placebo-controlled trial with shrimp and when clinical manifestations are enrolled; * all patients with these characteristics will necessarily have to sign the informed consent for inclusion in the study. exclusion criteria: * women who are pregnant; * patients chronically treated with antihistamines or steroids; * those who deny consent to participate.

Keywords: shellfish tropomyosin mites food allergy